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PG-NAION: Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy

Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03851562
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
16.6
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (NOIANA).

Condition or Disease Intervention/Treatment Phase
  • Drug: Alprostadil 20 micrograms
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Prospective, Unicentric, Randomized, Parallel, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate Intravenous Infusion of Prostaglandins as Therapy in Patients With Anterior Non-arteritic Ischemic Optic Neuropathy
Actual Study Start Date :
Jun 13, 2018
Anticipated Primary Completion Date :
Jun 13, 2019
Anticipated Study Completion Date :
Oct 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alprostadil 20 micrograms

1 μg / kg patient weight up to a maximum of 60 μg

Drug: Alprostadil 20 micrograms
Intravenous infusion of PGE1 (Days 0, +1 and +2)
Placebo Comparator: Placebo (physiological saline solution)

Placebo (physiological saline solution)

Drug: Placebo
Intravenous infusion of physiological saline solution

Outcome Measures

Primary Outcome Measures

  1. determination of visual acuity [Change from baseline visual acuity at 90 days.]

    Test ETDRS (Early Treatment Diabetic Retinopathy Study)

Secondary Outcome Measures

  1. Number of Serious Adverse Events [Day 1, day +4,day+30 , day +90.]

    Adverse Event

  2. Intraocular Pressure [Day1,day+30 , day +90.]

    Intraocular Pressure

  3. Visual Field [Day1,day+30 , day +90.]

    Humphrey Field Analyzer (HFA),

  4. Thickness of the layer of nerve fibers and ganglion cells in the retina [Day1,day+30 , day +90.]

    Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

  5. fundoscopic evaluation [Day1,day+30 , day +90.]

    Biomicroscopy

  6. Hemodynamic indices of the ocular arteries [Day1,day+30 , day +90.]

    Doppler SIEMENS Antares™ System:

  7. Optical disc area and cup / disc [Day1,day+30 , day +90.]

    Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Patients of both sexes between the ages of 50 and 80, both inclusive. Patients with the first episode of ischemic optic neuropathy previous non-arteritic / NOIANA. Patients with NOIANA with an evolution time from the beginning of the clinic less than or equal to 15 days.

  • Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG / human chorionic gonadotropin) or urine.

  • Patients who offer sufficient guarantees of adherence to the protocol.

  • Patients who give written informed consent to participate in the study.

Exclusion Criteria:

  • Patients with previous optic of any etiology in the affected eye.

  • Patients with previous diagnosis or symptoms at the time of arteritis of the temporal artery.

  • Patients with optic neuropathy with bilateral clinical presentation of any etiology.

  • Patients with loss of vision due to acute hypotension in the context of a surgical intervention, acute hemorrhage or hemodynamic shock.

  • Patients with severe loss of previous vision in the eye affected by ophthalmologic causes: severe cataract, glaucoma or intraocular pressure greater than 30 millimeters of mercury, severe diabetic retinopathy, macular degeneration associated with severe age.

  • Patients with clinical onset in the month following major non-ocular or intraocular surgery

  • Patients with abnormal elevation of CRP / C-reactive protein (> 2 times the upper limit of normal)

  • Patients with creatinine levels above 1.5 mg / dL.

  • Patients on steroid treatment in the month prior to the episode.

  • Patients under treatment with oral anticoagulants.

  • Patients on treatment with hydroxychloroquine, ethambutol, vigabatrin at any time before the episode.

  • Patients in whom the use of PGE1 (Alprostadil) is contraindicated:

  • Patients with participation in a clinical trial in the last 6 months.

  • Patients with inability to understand informed consent.

  • Pregnant patients, in the postpartum period or during the active lactation period.

  • Physically fertile patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain 30120

Sponsors and Collaborators

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT03851562
Other Study ID Numbers:
  • FFIS/PG/2017/03
First Posted:
Feb 22, 2019
Last Update Posted:
Feb 25, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Ischemia
Alprostadil

Study Results

No Results Posted as of Feb 25, 2019